510(k) Report

FDA applicant

Ameda, Inc.

Buffalo Grove, IL2 decisions2021–20220 recalls

FDA records 2 decisions for Ameda, Inc. (Buffalo Grove, IL) from 2021 to 2022: 2 510(k) clearances. All are in product code HGX (Pump, Breast, Powered). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Ameda, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2021: 12022: 1
2021high 1 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Ameda, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ameda, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HGXPump, Breast, Powered2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K203570Mya Joy PLUS Breast PumpAmeda, Inc. · 20211cites it

What has FDA decided for it lately?

  • K221576Ameda Pearl Electric Breast PumpAmeda, Inc. · 2022
  • K203570Mya Joy PLUS Breast PumpAmeda, Inc. · 2021

All 2 as Ameda, Inc. →

Other applicant names beginning “Ameda”

FDA records each applicant name separately; these may or may not be the same firm.

Ameda Medizintechnik AG 1